UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056018 |
|---|---|
| Receipt number | R000064016 |
| Scientific Title | Randomized Controlled Trial on the Effects of E-learning Education Program of Adequate Weight-Focused Preconception Care for Female Students in Higher Education |
| Date of disclosure of the study information | 2024/11/02 |
| Last modified on | 2026/03/12 16:33:51 |
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Basic information
Public title
Randomized Controlled Trial on the Effects of E-learning Education Program of Adequate Weight-Focused Preconception Care for Female Students in Higher Education
Acronym
The Effects of E-learning Education Program of Adequate Weight-Focused Preconception Care
Scientific Title
Randomized Controlled Trial on the Effects of E-learning Education Program of Adequate Weight-Focused Preconception Care for Female Students in Higher Education
Scientific Title:Acronym
The Effects of E-learning Education Program of Adequate Weight-Focused Preconception Care
Region
| Japan |
Condition
Condition
Pre-pregnancy low body weight
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and evaluate the preconception care E-learning educational program focused on adequate weight for female students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preconception care knowledge of women's weight before pregnancy
Awareness of the importance of adequate weight in preconception
Increased awareness of the benefits of implementing healthy behaviors towards an adequate weight
Self-efficacy for healthy behaviors
[Evaluation: Before provision of E-learning, immediately after the provision of E-learning, and 4 weeks later]
Implementation of healthy behaviors
[Evaluation: Before provision of E-learning, and 4 weeks later]
Key secondary outcomes
E-learning educational program evaluation
[Evaluation: Immediately after the provision of E-learning]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
E-learning educational program (Once)
Interventions/Control_2
Non-intervention
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
Female students enrolled in a graduate school, university, junior college or professional training college in Tokyo.
Those who have ICT skills and internet access.
Those who can read, write, and listen in Japanese.
Key exclusion criteria
Those who have experienced pregnancy or childbirth.
Those who have been diagnosed with an eating disorder or cannot eat due to psychological factors.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mami |
| Middle name | |
| Last name | Hagihara |
Organization
Japanese Red Cross College of Nursing
Division name
Graduate School of Nursing Science
Zip code
150-0012
Address
4-1-3 Hiroo Shibuya-ku,Tokyo
TEL
03-3409-1037
221D108@redcross.ac.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Hagihara |
Organization
Japanese Red Cross College of Nursing
Division name
Graduate School of Nursing Science
Zip code
150-0012
Address
4-1-3 Hiroo Shibuya-ku,Tokyo
TEL
03-3409-1037
Homepage URL
221D108@redcross.ac.jp
Sponsor or person
Institute
Japanese Red Cross College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Education, research and scholarship fund of Japanese Red Cross Academy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Japanese Red Cross College of Nursing
Address
4-1-3 Hiroo Shibuya-ku,Tokyo
Tel
03-3409-0875
kenkyurinri-jimu@redcross.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 01 | Day |
Last modified on
| 2026 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064016
